Kalydeco

Medicinal product

(Invented) name

Kalydeco

Active substance (s)

Ivakaftoras

Strength

150 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R07AX02, Ivacaftor

Marketing authorisation holder

Vertex Pharmaceuticals (Ireland) Limited, Airija

Date of authorisation

2012-07-23

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Ivakaftoras	150 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
53161	67103	1067103	buteliukas	N56		Receptinis	EU/1/12/782/001	Netiekiama	-	-	No	-	-
53162	67104	1067104	lizdinė plokštelė	N56		Receptinis	EU/1/12/782/002	Netiekiama	-	-	No	-	-
100427	86536	1086536	lizdinė plokštelė	N28		Receptinis	EU/1/12/782/005	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-07-23	Registruotas